FDA査察に立ち会って

今週、筆者はある医療機器企業のFDA査察に立ち会った。
12月に査察予告があってから3ヶ月間にわたり万全な準備を行った甲斐もあり、指摘ゼロ(NAI:No Action Indicated)で終了することができた。

成功要因として考えられることを列記してみたい。

1.開始時に社長、役員等がご挨拶したこと。
2.社長から、質問に対して正直かつ誠意をもって答えることをコミットして頂いたこと。
3.同様に社長から査察官に対して、査察に最大限協力する旨を伝えて頂いたこと。
4.想定問答集を作成し、リハーサル(模擬査察)を何度も繰り返したこと。
5.監査を実施し、微細な問題点に至るまで指摘を出し、CAPAによって改善を図ったこと。
6.日本語のSOPのままの説明では誤解を生じる恐れがあるため、プロセスのフローを英語で作成し、手順の説明に先立って簡潔に説明を行ったこと。
7.SOPや記録に関して、電子で検索し素早く提示したこと。(CSVやPart11については何も問われなかった。)
8.資料が紙媒体の場合は、検索の訓練を繰り返し行い、素早く適切な資料を提示できたこと。
9.査察官に対する敬意をもって接したこと。
10.査察官に対しておもてなしをしたこと。

1.に関して、企業のトップが品質システムを構築し、従業員を統制していることをアピールすることは重要である。
ともすると日本ではボトムアップ的な組織になりがちであるが、欧米ではトップダウンが常識である。
2.に関して、米国は正義を重んじる国である。したがって、嘘や不正、言い訳は禁物である。
5.に関しては、FDAの査察官は改善事項を発見し指摘するのであるが、企業が自ら監査により指摘を行い、改善していたならば指摘されることが少なくなるのである。
7.に関してはこれまで何度も解説を行ってきたが、SOPや記録を見せるためにコンピュータシステムを使用していたとしても、CSV実施やPart11対応は気にする必要はない。
そもそもCSV実施やPart11対応が重要なシステムは、医薬品や医療機器の有効性・安全性・品質に関する生データを取り扱うものである。
FDAの査察官は、紙媒体による資料を検索する時間を待つよりも、電子で素早く提示してもらいたいと考えているのである。
9.10.に関しては、実はかなり重要である。
査察官も人間である。異国の地に来て、言葉が通じなく、時差ボケもあり、不安である中、査察官をVIPとして扱い、おもてなしをすることは査察官に非常に好印象を与える。
食事や宿泊、部屋の温度なども気を使う必要がある。
FDA査察が実施される1週間は緊張の連続であるが、実は査察官も緊張している。
査察官はけっして敵ではない。
しばしば査察時に資料をストックしておく部屋(バックヤード)を「War Room」と呼んでいる企業を耳にするが、好ましくない。
種々のFDA査察対応ノウハウに関しては、セミナーでご紹介したいと思う。

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